Living Better with Chemistry: Regulating with Drugs Joel Lexchin MD School of Health Policy and Management, York University Emergency Department, University Health Network

Living Better With Chemistry An exploration of the use of antipsychotic medications for residents of long-term care facilities

Regulation? What is regulation for? – Ensure that antipsychotic medications are being used in the best interests of residents Who is doing the regulation? – Government, provincial colleges of physicians, long- term care residences Who is being regulated? – People doing the prescribing (mostly doctors) Regulation & privatization – Quality of prescribing and ownership

Number and Percent of Residents in LTC Homes With Cognitive Impairment 2006: 275,000 LTC residents x 60% = 165,000 with moderate to severe cognitive impairment

Percent of Residents Using Antipsychotics Across Canada about 30% receive these drugs – Wide variation among LTC homes from about 20 – 45% – Recent estimate from BC – 50.3% of residents (unknown how long medication is being used for) – Within 100 days of admission 17% of residents who had never used an antipsychotic received Rx for one (24% by one year) – Amongst those with dementia 52% of those in LTC homes receive antipsychotics versus 21.3% of those living in community

Cross National Survey (2003)

Reasons for Using Antipsychotics Cognitive impairment leading to disruptive behavioural symptoms of dementia – Aggression, problems with sleep, wandering Use of antipsychotics for these reasons is off- label, i.e., hasnt been approved by Health Canada – In US 83% of use of these drugs is off-label

Sleep Disorders 12 nursing homes in Massachusetts Reduction in the use of antipsychotics had no effect on the percent of residents experiencing sleep disorders

Behavioural Problems Database study in Netherlands – 556 residents started on antipsychotics, at 3 months: 101 (18.2%) improved 260 (46.8%) deteriorated 195 (35%) stable Those with severe challenging behaviour showed more improvement – 520 residents discontinued antipsychotics, at 3 months 155 patients (30%) improved 168 (32%) worsened 197 (38%) stable

Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimers Disease Olanzapine, quetiapine and risperidone Cognitive benefits – Over the course of 36 weeks, atypical antipsychotics were associated with worsening cognitive function at a magnitude consistent with 1 years deterioration compared with placebo Psychosis, aggression or agitation – improvement was observed in 32% of patients assigned to olanzapine, 26% of patients assigned to quetiapine, 29% of patients assigned to risperidone, and 21% of patients assigned to placebo

Elderly With Dementia and Psychosis, Mood Alterations and Aggression 3 meta-analyses – Not all trials involved patients in LTC residences – Overall some evidence of benefit but also significant harms

Adverse Events Associated With Beginning Antipsychotic Therapy

US - Omnibus Budget Reconciliation ACT 1987 (OBRA 87) Each residents drug regimen must be free from unnecessary drugs Resident has the right to be free from any psychoactive drug administered for purposes of discipline or convenience and not required to treat the residents medical symptoms Facility must ensure that residents who have not used antipsychotic drugs before are not given these drugs unless such drug therapy is necessary to treat a specific condition

Despite OBRA 87 22% of atypical antipsychotic drugs were not administered in accordance with standards set by the Centers for Medicare & Medicaid Services Between 23 to 32% of those prescribed this group of drugs had no indication for these drugs Antipsychotic use increased 7.4 percentage points from 1999 to 2006 – Reflects both increasing proportions of residents diagnosed with schizophrenia, bipolar disorder, dementia, depression, or anxiety disorder and an increase in antipsychotic treatment rates within each diagnostic category

Canada and OBRA 87 Unlikely to be feasible LTC homes are not covered under the provisions of Medicare & therefore federal government does not contribute any money for them and therefore lacks any method of enforcing legislation Care in LTC homes is part of the delivery of health care and is therefore a provincial responsibility No province has enacted any similar legislation & Saskatchewan specifically rejected a legislated approach Only exception would be if antipsychotics were used as physical restraints – in BC would have to be consistent with provincial legislation (no consent required)

Other Regulation No provincial college has set out formal requirements for the use of these medications

Guidelines BC Medical Association & BC Ministry of Health: Clinical Practice Guideline on Cognitive Impairment in the Elderly: Recognition, Diagnosis and Management National Guidelines for Seniors Mental Health: The Assessment and Treatment of Mental Health Issues in Long Term Care Homes Canadian National Consensus Guidelines for Dementia Alzheimer Society of Canada: Guidelines for Care: Person-centred care of people with dementia living in care homes Guidelines have no regulatory force

Educational Efforts - International US – Outreach program for doctors, nurses and nursing assistants that emphasized alternatives to these drugs – Decrease use of 27% in the experimental homes versus 8% in the control homes – No difference between the two groups in disruptive behaviour UK – Emphasized issues such as environmental, care practice, and attitudinal factors through didactic training, skills modelling, and supervision of groups and individual staff – After 12 months, there were significantly fewer residents taking neuroleptics in the intervention homes (23.0%) compared to the control homes (42.1%) – No differences in the levels of agitated or disruptive behaviour

Educational Efforts - Canadian Montreal – Consciousness-raising, educational sessions, and clinical follow-up for administrators, physicians, pharmacists, nursing staff, and personal care attendants – Over 6 months among 81 residents there were 40 (49.4%) discontinuations of antipsychotics and 11 (13.6%) dose reductions and the frequency of disruptive behaviors decreased significantly Alberta – Two-month series of educational sessions for physicians, facility pharmacists, nursing staff and family members – No significant decline in the use of antipsychotics in the intervention facilities versus controls

Prescribing Behaviour Saskatchewan – 17 – 47% of prescriptions depending on drug were for higher than recommended doses Alberta – Dose reduction attempted in only 16% of cases at 6 months

Physician Characteristics Associated With Prescribing Antipsychotics Interview with 9 doctors in the Montreal area who prescribed antipsychotics to community- dwelling seniors All of the physicians interviewed perceived the aging process as a negative experience and stated that the long-term use of psychotropic medication is justified by the distress of their aging patients and the few negative side effects that are noticed. Skeptical about nonpharmacological approaches

Lack of Appropriate Training for Doctors Canadian Patient Safety Institute – Physicians may not always have the best practice knowledge in terms of what medications are appropriate, lets say use of psychotropics as an example, for many people, psychotropics is totally inappropriate.

Doctors Acquisition of Knowledge

Antipsychotic Prescribing by Type of Ownership Manitoba – Odds of being dispensed antipsychotic medications were 1.7 times greater for residents of for-profit homes in the Winnipeg Regional Health Authority versus not-for-profit and public homes in Manitoba Minnesota – Medicare and Medicaid certified for-profit facilities had higher antipsychotic use rates than did not-for-profit facilities United States – All 14,631 Medicare and Medicaid certified homes – Antipsychotic use was higher in those operated on a for- profit basis versus those on a not-for-profit basis

Quality of Care and Type of Ownership BC for-profit versus not-for-profit facilities – Higher adjusted hospitalization rates for pneumonia, anemia, and dehydration – No difference for falls, urinary tract infections, or decubitus ulcers/gangrene – No difference in mortality rates Two meta-analyses (American data) – systematic differences exist between for-profit and not-for-profit nursing homes. For profit nursing homes appear to provide lower quality of care in many important areas of process and outcome – Not-for-profit facilities delivered higher quality care than did for-profit facilities for two of the four most frequently reported quality measures and for the two others there were non-significant results favouring not-for-profit homes

Conclusions Lack of regulation – Government and regulatory body about prescribing – About privatization Best interests of LTC residents are not being protected – More harms than benefits from prescribing